Services

Bioequivalence testing

Fast and efficient PK based bioequivalence testing of topical generics.

Our innovative dOFM (dermal open flow microperfusion) sampling technology provides dermal BE data using a PK based approach. Currently, FDA approval for topical generic drugs requires a clinical endpoint study to show bioequivalence (BE). Standard blood PK studies are not useful for BE tests of topical dermal generics. dOFM allows a PK based BE approach directly in the skin.

Our Services

dOFM offers a PK based BE approach for BE testing directly in skin
test and reference listed drug (RLD) are compared in the same subject at the same time
strategic consulting for product specific guidance and ANDA meetings (505b2, Product development meeting)
all services required for an FDA submission are provided by our team and partners

Our Expertise

one PK study instead of an expensive clinical endpoint study
less participants (< 50 healthy subjects) instead of hundreds of patients
single-center instead of multi-center trial
our approach has a reduced risk of failure compared to clinical endpoint studies

Learn more about Open Flow Microperfusion (OFM)